NCT03707080已完成不适用
DAA-PASS: A Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in HCV-Infected Patients After Direct-Acting Antiviral Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 61
- 主要终点
- Time to HCC recurrence - Prospective Cohort
研究概览
简要总结
This is an independent optional sub-study parallel to TARGET-HCC (NCT02954094). The purpose of Direct-Acting Antiviral-Post Authorization Safety Study (DAA-PASS) is to investigate the impact of exposure to direct-acting antivirals (DAAs) on early recurrence of hepatocellular carcinoma (HCC) in hepatitis C virus (HCV)-infected patients following successful HCC treatment interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current participant in TARGET-HCC
- •Adults, age ≥18 years
- •First diagnosis of HCC (mixed HCC/cholangiocarcinoma may be included). Diagnosis may be histological/cytological and/or radiological.
- •BCLC Stage A
- •Underwent, undergoing, or planned to undergo therapy for HCC, with exception that transplant as prior or planned treatment for HCC is excluded.
- •HCV RNA positive
排除标准
- •Inability to provide informed consent
- •HCC-free imaging (as defined in Section 9.1.1) after treatment of initial HCC prior to Screening (see Section 9.2.9 for imaging details)
- •Prior liver transplantation
- •Hepatitis B Virus (HBV) surface antigen positive (HBsAg)
- •Previously treated with direct-acting antiviral agents (not DAA-naïve); Note that prior (peg)IFN and/or ribavirin therapy is allowed
- •Enrollment Inclusion Criteria:
- •Continued participation in TARGET-HCC
- •No recurrence or progression of initial HCC beyond BCLC Stage A prior to Enrollment/Baseline
- •HCC-free imaging (as defined in Section 9.1.1) at Enrollment/Baseline (see Section 9.2.9 for imaging details; participants may remain in Screening until an HCC-free image is obtained)
- •Remains DAA-naïve (prior therapy with (peg)IFN and/or ribavirin is allowed)
- •Enrollment Exclusion Criteria:
- •Liver transplantation since Screening
结局指标
主要结局
Time to HCC recurrence - Prospective Cohort
时间窗: up to 24 months
Time to HCC recurrence associated with DAA therapy relative to no DAA therapy in the prospective cohort.
次要结局
- Number of events of early HCC recurrence - Prospective Cohort(up to 24 months)
- Number of events of early HCC recurrence - Prospective Cohort relative to Historical Cohort(up to 24 months)
- Time to HCC recurrence - Prospective Cohort relative to Historical Cohort(up to 24 months)
研究者
研究点 (61)
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